Resolute
A Multicenter, Randomized, Double-blind, Chronic-dosing, Parallel-group, Placebo-controlled Phase 3 Study to Evaluate the Efficacy and Safety of Benralizumab 100 mg in Patients with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) with a History of Frequent COPD Exacerbations and Elevated Peripheral Blood Eosinophils (RESOLUTE)
- Sex at Birth: Any
- Age: Adult (18 - 64), Older Adult (65+)
- Accepting Healthy People: No
- Type: Interventional / Therapeutic
- Trial Phase: Phase III
- Conditions Being Studied: Pulmonary Diseases
Study Purpose
This study is being carried out to evaluate benralizumab (study drug) compared to placebo (an inactive substance) as a medicine to treat moderate to very severe COPD associated with elevated blood eosinophils and history of frequent exacerbation (also known as 'flare ups'). Benralizumab is not approved by any health authority for treatment of COPD, except for use in research studies like this. Benralizumab is an approved treatment for severe eosinophilic asthma in the US, Europe, Canada and other countries under the trade name Fasenra.
Locations
UH Cleveland Medical Center
11100 Euclid Avenue
Cleveland OH, 44106
- UH IRB: STUDY20200204
- StudyID: STUDY20200204
- ClinicalTrials.gov: NCT04053634
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